Effect of Ascending dose of F-627 in Healthy Male Volunteers
- Conditions
- eutropeniaNeutropeniaBlood - Haematological diseases
- Registration Number
- ACTRN12610000363088
- Lead Sponsor
- ucleus Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 24
* Subjects must be healthy male volunteers
* Subjects must have a body mass index greater than or equal to 19 (kg/m2)and less than or equal to 34 (kg/m2).
*No clinically significant findings in the medical and physical examination, especially normal full blood count (at screening), hepatic and renal function.
* Family history of premature CHD (Coronary Heart Disease)
* Any condition which can cause splenomegaly
* Exposure to prescription medications or to drugs known to interfere with metabolism of drugs within 30 days prior to screening
* Prior history of a haematological malignancy, or current history of a haematological disorder (even if it does not require treatment)
* Any abnormality of red cell count, mean corpuscular volume,platelet count, white cell count or white cell differential
* Subjects at risk of tuberculosis (TB)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of F-627 at 30ug/kg, 60ug/kg,120ug/kg & 240ug/kg will be assessed on the basis of adverse events reported (such as spenomegaly, bone pain) , vital signs , routine safety blood samples (clinical chemistry, haematology) and abdominal ultrasound for the assessment of splenomegaly.[Patients will be continuously monitored whilst they are on study as an inpatient for 3 days following dose administration, and then via a series of clinic visits at Days 4,5,6,7,9,11,13 and 15 post study drug administration.]
- Secondary Outcome Measures
Name Time Method To assess the affect of a single subcutaneous dose of 30ug/kg, 60ug/kg, 120ug/kg & 240ug/kg of F-627 in healthy adult male volunteers via pharmacokinetic/ pharmacodynamic effects of F-627 as assessed by blood analysis.[Patients will be continuously monitored whilst they are on study as an inpatient for 3 days following dose administration, and then via a series of clinic visits on Days 4,5,6,7,9,11,13 and 15 post study drug administration.]